Omnipaque 240mg/ml Inj, 100ml

Iohexol is a nonionic, water-soluble, tri-iodinated benzoic acid derivative. It enhances the visibility of structures in X-ray imaging by absorbing X-rays. When injected intravascularly, it distributes into the extracellular fluid space, providing contrast for blood vessels and tissues. Its high iodine content and low osmolality contribute to its efficacy and safety profile.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Thyroid problems: Changes in weight, feeling nervous, excitable, restless, or weak, hair thinning, depression, eye or neck swelling, difficulty focusing, trouble with heat or cold, menstrual changes, shakiness, or sweating.
Injection-related side effects:
+ Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
+ Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
+ Severe dizziness or fainting.
+ Shortness of breath, significant weight gain, or swelling in the arms or legs.
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm.
+ Seizures.
+ Changes in vision.
Tissue damage: If the medication leaks from the vein, it can cause tissue damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Severe skin reactions: These can occur anywhere from 1 hour to several weeks after receiving the medication and may include:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect body organs and be life-threatening.
+ Symptoms may include: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Spinal injection side effects: A burning, numbness, or tingling sensation that is not normal.
Liquid formulation side effects: Swelling.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Common side effects:
+ Upset stomach or vomiting
+ Headache
Injection-related side effects (if given in an artery or vein):
+ Dizziness
+ Feeling of warmth
+ Changes in taste
Injection-related side effects (if given into the spine):
+ Dizziness
+ Back pain
+ Neck pain
+ Stiff neck
* Liquid formulation side effects:
+ Stomach pain or diarrhea
+ Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment with this medication:

Allergies: If you have any allergies to this drug, its components, or other medications, foods, or substances. Describe your allergic reactions and the symptoms you experienced.
Dehydration and poor nutrition: If you are dehydrated, have been eating poorly, or have recently used laxatives or diuretics.
Previous skin reactions: If you have had a skin reaction to this medication or similar drugs in the past.
Concurrent medications: If you are taking metformin or any other medications that may interact with this drug.

Additional considerations for specific administration routes:

Spinal injection: Inform your doctor if you have an active infection or are taking medications that may increase the risk of seizures, including any medications taken within the last 48 hours.
Injection into an artery or vein: Tell your doctor if you have urinary retention or are unable to pass urine.
* Use before an x-ray of the uterus and fallopian tubes: Inform your doctor if you are menstruating, have a genital infection, or have a suspected or confirmed growth in the reproductive tract. Also, notify your doctor if you have had a curettage or conization procedure within the past 30 days, or if you have had a pregnancy terminated within the last 6 months.

Pregnancy and breastfeeding: Do not take this medication if you are pregnant or suspect you may be pregnant.

Interactions with other medications and health conditions: This is not an exhaustive list of potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may need to monitor your blood work, and this medication may affect certain lab tests. Be sure to notify all your healthcare providers and lab workers that you are taking this drug.

If you experience any signs of kidney problems, such as difficulty urinating, changes in urine output, bloody, brown, or foamy urine, shortness of breath, cough, or swelling in your face, feet, or hands, contact your doctor immediately.

Special Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of side effects may be higher in some children.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

Injection (Given in an Artery or Vein)

In children under 3 years of age, the use of medications like this one has been associated with low thyroid function, which can impact child development. If the patient is a child, your doctor may need to monitor their thyroid function for a period after the injection. If you have questions or concerns, discuss them with your doctor.

Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have occurred with this medication. Consult your doctor to discuss the risks and benefits.

Additionally, health problems like blood clots have been reported with this medication when used in conjunction with certain procedures. In some cases, blood clots can lead to heart attack and stroke, which can be fatal. If you have questions or concerns, discuss them with your doctor.

Injection (Given into the Spine)

This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

• Metformin (in patients with renal impairment or anticipated renal impairment)
• Interleukin-2 (IL-2) (increased risk of delayed adverse reactions)

• Beta-blockers (increased risk of severe hypersensitivity reactions, reduced efficacy of epinephrine)
• Diuretics (increased risk of dehydration and subsequent contrast-induced nephropathy)
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides) (increased risk of contrast-induced nephropathy)

• Hives
• Itching
• Rash
• Swelling of face/throat/tongue
• Difficulty breathing
• Wheezing
• Chest tightness
• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Flushing
• Metallic taste
• Pain or discomfort at injection site
• Signs of delayed reaction (e.g., skin rash, fever, joint pain) days after administration

Category B. Animal studies have not shown fetal harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Consider non-ionizing imaging modalities if possible.

L2 (Safer). Iohexol is excreted in breast milk in very small amounts (less than 0.5% of the administered dose). The amount absorbed by the infant is negligible. Breastfeeding can generally be continued without interruption. If concerns exist, a temporary interruption (e.g., 6-24 hours) and discarding milk may be considered, but is often not necessary.

Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Careful attention to hydration, dose calculation, and monitoring for adverse reactions is crucial. Risk of contrast-induced nephropathy is lower than in adults but still a concern in vulnerable populations.

Increased risk of contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose and ensure adequate pre- and post-hydration.

• Always assess renal function (eGFR) before administering iohexol, especially in patients with risk factors for CIN.
• Ensure adequate hydration before and after contrast administration to minimize the risk of CIN.
• Hold metformin for 48 hours after contrast administration in patients with pre-existing renal impairment or if acute kidney injury is suspected, and restart only after renal function is confirmed to be stable.
• Be prepared for immediate hypersensitivity reactions; have resuscitation equipment and medications readily available.
• Nonionic contrast agents like iohexol generally have a lower incidence of adverse reactions compared to older ionic agents.
• Patients with a history of prior contrast reactions may require premedication (e.g., corticosteroids, antihistamines) or consideration of alternative imaging modalities.

• Iodixanol (Visipaque - another nonionic, iso-osmolar contrast agent)
• Iopamidol (Isovue - another nonionic, low-osmolar contrast agent)
• Ioversol (Optiray - another nonionic, low-osmolar contrast agent)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Ultrasound (non-ionizing imaging)
• Non-contrast CT or MRI (if diagnostic information can be obtained without contrast)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.